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In Case You Missed It:

What to do about postmenopausal fracture risk

Published: December, 2009

Diet, exercise, calcium, and vitamin D are always important,
but women at high risk for fractures may need drug therapy,
too.

If you're over age 50, you have an even lifetime chance of
breaking a bone because of osteoporosis. This disorder weakens
bones, leaving them vulnerable to fracture even without a serious
fall or other trauma. The risk increases with age in both sexes,
but postmenopausal women are at special risk because bone loss is
accelerated by the decline in estrogen at menopause.

In 1994, the World Health Organization (WHO) developed criteria
for diagnosing osteoporosis based on a measurement of bone
mineral density (BMD) called a T-score. These scores are best
determined by dual-energy x-ray absorptiometry (DXA). A T-score
of –2.5 or lower marks the threshold for osteoporosis and the
point at which treatment is clearly indicated.

But BMD measurements alone can't predict who's most likely to
break a bone — the main reason for concern about osteoporosis.
Among postmenopausal women, as many as half of all fractures
occur in those whose T-scores don't meet the criteria for
full-blown osteoporosis. Moreover, women with the same T-scores
don't necessarily have the same fracture risk. For example, one
study concluded that an 80-year-old woman with a T-score of –2.5
was almost five times more likely to break a bone than a
50-year-old woman with the same T-score.

In 2008, a WHO task force introduced FRAX, a risk assessment tool
that incorporates a number of risk factors besides BMD. (See
"Risk factors used in FRAX.") FRAX provides an estimate of the
likelihood that you will suffer a hip or other major fracture in
the next 10 years. Using this tool, the National Osteoporosis
Foundation has issued new guidelines that are helping to clarify
who should be tested and treated.

Who needs treatment?

Most experts recommend DXA screening for all women ages 65 and
over, as well as younger women who have risk factors associated
with bone loss. That includes women over 50 who have a low body
mass index, a history of low-trauma fracture as an adult, or a
condition associated with bone loss, such as celiac disease,
Crohn's disease, rheumatoid arthritis, or anorexia nervosa. A
woman who is taking certain medications, including
glucocorticoids, chemotherapy drugs, immunosuppressants, or
certain anticonvulsants is also at increased risk of bone loss
and may benefit from DXA testing before age 65. Women who
discontinue estrogen therapy lose bone rapidly, just like those
in the first few years of menopause.

The FRAX tool (available online at www.shef.ac.uk/FRAX) is designed
to assess postmenopausal women's fracture risk even without BMD
measurement. (In the United States, where DXA is widely
available, the FRAX formula may soon be added to DXA software,
providing results that incorporate both T-scores and FRAX risk
estimates.) The National Osteoporosis Foundation guidelines
suggest that clinicians consider treatment with an FDA-approved
drug for women (and men) ages 50 and over who meet one or more of
the following criteria:

a history of hip or spine fracture

a T-score of less than –2.5 at the hip or spine

a T-score of –1.0 to –2.5 at the hip or spine (indicating low
bone mass short of osteoporosis) together with a 10-year,
FRAX-estimated risk of more than 20% for any major
osteoporosis related fracture or more than 3% for
hip fracture.

Keep in mind that falls are one of the biggest risks for
fractures. There are many strategies for preventing falls and the
resulting broken bones, including home safety precautions and
exercises to improve strength and balance. (Fall prevention
resources are available at www.stopfalls.org.)

Anyone taking an osteoporosis medication should also get adequate
calcium and vitamin D. Aim for a calcium intake of 1,200 to 1,500
milligrams daily, mostly through foods, which have many important
nutrients in addition to calcium. The National Osteoporosis
Foundation currently recommends 800 to 1,000 international units
(IU) of vitamin D per day, but some experts think that isn't
enough. Up to 2,000 IU per day is considered safe.

Medications for prevention or treatment of postmenopausal
osteoporosis

Drug name

Brand name

For prevention, treatment, or both

How taken (and how often)

Fracture reduction by type

Approx. monthly cost

Bisphosphonates

alendronate

Fosamax

both

oral (daily or weekly)

vertebral, hip, other

$80–$95

risedronate

Actonel

both

oral (daily, weekly, or monthly)

vertebral, hip, other

$90–$100

zoledronic acid

Reclast

treatment only

IV1 (once yearly)

vertebral, hip, other

$1052

ibandronate

Boniva (oral)

both

oral (monthly)

vertebral

$100

Boniva (IV1)

treatment only

IV (once every 3 months)

vertebral

$485

Selective estrogen receptor modulator
(SERM)

raloxifene

Evista

both

oral (daily)

vertebral

$100

Hormones

estrogen

Premarin

prevention only

oral (daily)

vertebral, hip, other

$35–$45

estrogen plus progestin

Prempro, Premphase

prevention only

oral (daily)

vertebral, hip, other

$40–$55

calcitonin

Fortical

treatment only

nasal spray (daily)

vertebral

$115

Miacalcin

treatment only

injection (every other day)

vertebral

$425

Teriparatide (parathyroid hormone)

Forteo

treatment only

injection (daily)

vertebral, other

$845

1IV=intravenous.

2Based on yearly cost averaged over 12 months.

Source: Fracture Prevention Treatments for Postmenopausal
Women with Osteoporosis: Clinician's Guide, Agency for
Healthcare Research and Quality, 2008. Available at
http://effectivehealthcare.ahrq.gov.

Medication options

The main goal of treatment is to prevent fractures by slowing
bone loss or strengthening bone. Several medications are now
available for this purpose, and more are under development. Bone
continually undergoes remodeling, or bone turnover, in two
distinct phases — resorption (breakdown) and formation. Different
osteoporosis medications target different phases of the
remodeling process. Most approved drugs are antiresorptive — that
is, they protect existing bone from being broken down, or
resorbed. Only one, teriparatide (Forteo), directly stimulates
new bone formation. As with many drugs, it's unclear whether a
particular medication works best, because of the lack of
head-to-head trials comparing the effectiveness of these various
drugs in reducing fractures. (Most of what we know comes from
trials comparing individual drugs to a placebo.)

Currently available drugs (see "Medications for prevention or
treatment of postmenopausal osteoporosis" above) fall into three
main classes:

Bisphosphonates. These drugs, the
first-line medications for osteoporosis, slow bone resorption by
sticking to the surface of bone and interfering with osteoclasts
(the cells that break down bone). When resorption drops, so does
new bone formation, which is closely linked to resorption.
Consequently, antiresorptive drugs don't produce a big increase
in BMD. But that doesn't mean the drug isn't doing its job, says
Dr. Steven Harris, an osteoporosis expert at the University of
California at San Francisco. Speaking at the annual meeting of
the North American Menopause Society in October 2009, Harris
noted, "Antiresorptive therapy decreases fracture risk more
rapidly and to a larger extent than one would predict from the
small changes in BMD."

In women with osteoporosis, the oral bisphosphonates alendronate
(Fosamax) and risedronate (Actonel) reduce the risk of vertebral
(spine), hip, and nonvertebral (arm or wrist) fractures.
Ibandronate (Boniva) reduces vertebral fractures but has little
effect on nonvertebral or hip fractures. A key trial of
zoledronic acid (Reclast), which is given intravenously, found
that it reduced vertebral, hip, and nonvertebral fractures.

The biggest complaint about oral bisphosphonates is upper
gastrointestinal distress, including acid reflux, trouble
swallowing, heartburn, and nausea. (To help prevent these
problems, take the drug on an empty stomach first thing in the
morning with a large glass of water, and don't eat or lie down
for 30 to 60 minutes afterward.) A less common complaint is
muscle, bone, and joint pain. One potential side effect is very
serious but also very rare: osteonecrosis (bone death) of the
jaw. This problem has occurred mostly among cancer patients
taking high intravenous doses of bisphosphonates. The rare cases
among people taking lower doses for osteoporosis have generally
been in those undergoing invasive dental procedures. As a
precaution, women are advised not to have major dental work
performed while they're taking bisphosphonates. There are also
scattered reports of nontraumatic fractures of the thighbone in
people on long-term bisphosphonate therapy.

Selective estrogen receptor modulators
(SERMs). These are estrogen-like compounds that act
on estrogen receptors to slow osteoclast activity in
postmenopausal women. Raloxifene (Evista) is the only SERM
approved so far for osteoporosis prevention and treatment. In
women with low BMD, raloxifene helps reduce vertebral fractures
but has little effect on nonvertebral or hip fractures. It's also
approved for the prevention of breast cancer. Side effects
include exacerbation of hot flashes and increased risk of blood
clots and stroke. Raloxifene is preferable mainly for women who
can't tolerate the side effects of bisphosphonates or are at
increased risk for breast cancer.

Hormones. Medications in this category
include estrogen with or without a progestin (hormone therapy),
calcitonin (Miacalcin, Fortical), and Forteo.

Many randomized trials have shown that hormone therapy reduces
the risk of vertebral, hip, and nonvertebral fractures. Before
the Women's Health Initiative found that its risks outweighed its
benefits, hormone therapy was routinely prescribed for long-term
prevention and treatment of osteoporosis. The National
Osteoporosis Foundation and the North American Menopause Society
say that other medications should be considered first, but that
hormone therapy may be an option if alternative therapies aren't
suitable or cause intolerable side effects. Currently, it is
approved only for osteoporosis prevention.

Calcitonin, a thyroid-derived peptide, slows bone resorption and
can reduce the risk of new vertebral fractures. It may also help
reduce pain caused by vertebral fracture. However, calcitonin is
not first-line therapy. It's expensive and has frequent and
annoying side effects, including nausea, flushing, and (when
taken in a nasal spray) nasal irritation. It also doesn't reduce
hip or nonvertebral fractures.

Forteo, a synthetic preparation of human parathyroid hormone
given by daily injection, is the only approved osteoporosis drug
that works by boosting the formation of bone rather than slowing
its breakdown. In women with severe osteoporosis, Forteo
significantly reduces the risk of vertebral and nonvertebral
fractures. It has relatively few short-term side effects, but its
long-term safety hasn't been established. It's also expensive and
burdensome to administer, so it's usually reserved for women at
very high risk for fracture. Other versions of human parathyroid
hormone are under investigation.

On the horizon

Several drugs that target bone resorption are in development or
awaiting FDA approval. Two, bazedoxifene and lasofoxifene, are
orally administered SERMs. In clinical trials, bazedoxifene
reduced vertebral but not nonvertebral fracture risk;
lasofoxifene lowered the risk of vertebral and nonvertebral
fracture, as well as heart disease, stroke, and breast cancer.
Another antiresorptive drug, denosumab, targets a protein
required for making osteoclasts. Clinical trials indicate that it
reduces vertebral, hip, and nonvertebral fractures.

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Daily Health Tip

Don't snack late at night

If you find yourself snacking at night before bed, it may be because you're bored or anxious — not truly hungry — and eating makes you feel better. Try eating a healthy dinner a bit later in the evening. If your stomach is truly growling before bed, try a protein-based snack like a hard-boiled egg or a slice of cheese. A few spoonfuls of yogurt or some fruit is another good option.